Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.

Antonio Mestrovic

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Hybrid therapy; Drug: Concomitant therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03572777

003-08/18-03/0001

Details and patient eligibility

About

The aim of the study is to compare the effectiveness of two therapeutic protocols in the treatment of Helicobacter pylori infection.

The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients.

In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose.

The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Helicobacter pylori infection (documented by: positive antigen stool test, or positive urease rapid test obtained during upper endoscopy, or Helicobacter pylori in histological finding, or positive C-urea breath test; according to recent Maastricht V guidelines;
• written informed consent

Exclusion criteria

• age under 18
• previously treatment of Helicobacter pylori infection
• malignancy of stomach or other site
• history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month
• significant underlying disease (renal failure, psychiatric disorders)
• history of allergic reactions to any medications used in study
• refuse to participate in study
• breastfeeding and pregnancy
• quitting the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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159 participants in 2 patient groups

Concomitant therapy

Active Comparator group

Description:

Amoxicillin ('Amoksicilin') 1 g bid, metronidazole ('Medazol')500 mg bid, clarithromycin ('Makcin')500 mg bid and esomeprazole ('Emanera')40 mg bid for 14 days.

Treatment:

Drug: Concomitant therapy

Drug: Concomitant therapy

Drug: Concomitant therapy

Drug: Concomitant therapy

Hybrid therapy

Active Comparator group

Description:

Amoxicillin ('Amoksicilin') 1 g bid and esomeprazole ('Emanera') 40 mg bid for 14 days, with metronidazole ('Medazol')500 bid and clarithromycin ('Makcin') 500 mg bid for the last 7 days.

Treatment:

Drug: Hybrid therapy

Drug: Hybrid therapy

Drug: Hybrid therapy

Drug: Hybrid therapy